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奧法美嘉科技有限公司
奧法美嘉科技有限公司
SingleParticleOpticalSizingTheAccuSizer780usesthemethodofsingle-particleopticalsizing(SPOS)toquicklycountandsizealargenumberofparticles
Single Particle Optical Sizing The AccuSizer 780 uses the method of single-particle optical sizing (SPOS) to quickly count and size a large number of particles, one at a time, thus constructing the true particle size distribution (PSD). This approach is in sharp contrast to "ensemble" methods, such as laser diffraction and sedimentation, which must process information produced simultaneously by many particles. These alternative techniques require the use of complex mathematical algorithms to invert the data and yield only rough approximations of the PSD, with limited accuracy and very poor resolution. The AccuSizer determines PSDs with resolution and accuracy comparable to those produced by the classical resistive-pore, or electrozone, method. The 780 does not miss the "details", which are often critically important in determining the quality of many products. A wider size range, higher count rate, compatibility with any liquid or gas, and relative immunity to clogging make it an instrument in a class all its own. The SPOS particle sizing method requires that concentrated suspensions be diluted, in order to eliminate particle coincidences in the sensing photozone. Excessive dilution results in too low a count rate and poor statistical accuracy of the PSD, while overly concentrated suspensions produce distortions in the distribution. The AccuSizer 780 uses AutodilutionPat, which quickly and automatically dilutes the starting sample to the optimum concentration, resulting in efficient and accurate analysis. Trial-and-error manual dilution is eliminated, paving the way for single-keystroke operation; a complete analysis and flush cycle can be completed in less than 3 minutes. The 780*s single particle sensitivity detects the important features in the size distribution which other techniques usually miss. Single particle optical sensing makes the measurement accurate, while AutodilutionPat and leading-edge electronics make it fast and easy to use. Trading off accuracy and resolution for speed and ease of use no longer have to be made with the AccuSizer 780. The AccuSizer 780 delivers reliable size and count data for even the largest particles.A few outliers can spell the difference between product success and failure; however traditional laser diffraction particle size analyzers cannot detect large particle outliers in a sea of smaller particles.The AccuSizer 780 reveals particle size differences that previously went unnoticed.The 780 is a stable, sensitive instrument that uses Single Particle Optical Sizing (SPOS) to count and size particles one at a time, eliminating missed particles while allowing:
Recently,an independent study proved that SPOS analyzers were 1,500 to 25,000 times more sensitive in detecting outliers than light scattering and accoustical sizing instruments. The AccuSizer 780 can also resolve fine particle distributions that are directly related to the materials' properties. It is a proven and valuable tool that laboratories around the world are already using to reformulate their product lines from R&D to production. A modular solution to meet your most challenging applications The AccuSizer 780 AD Autodiluter is the cornerstone of the modular family of instruments. The AccuSizer 780 AD incorporates a series of wide dynamic range sensors with a single stage exponential diluter to provide a flexible high resolution, accurate, sensitive particle sizer. It provides particle size information with unprecedented resolution and accuracy. It is especially suited to providing information on particle size distributions (PSDs) that are on scale but is not limited in the statistical information that it can provide on tails of mostly submicron distributions. This patented module eliminates the need for manual dilution of concentrated samples. Autodilution makes particle size analysis quick and easy, with no training required. Results are highly reproducible. AccuSizer 780/APS Automatic Particle Sizer
The APS has been called the bolder detector by many of our customers because of its ability to detect low levels of aggregates several standard deviations away from the mean of the distribution. Often these aggregates are the difference between a good and bad sample. One independent study showed the APS was 1,500 to 25,000 times more sensitive in seeing outliers in the CMP slurry than commonly used laser light scattering and acoustical sizing instruments. The same sensitivity will apply to other applications such as inks, pigments, drug emulsions where a few large particles spell the difference between success and disaster. AccuSizer FX Focused Extinction
The AccuSizer FX is a new breed of particle size monitoring system designed to go from the R&D lab to the process line with minimum system reconfiguration. The FX utilizes a patented focused beam technology that allows the sensor to focus on a specific area of the flow channel to count and size individual particles at concentration levels that are hundreds of times higher than traditional sensors. Although this type of approach has been tried by other techniques it has been plagued by low resolution and accuracy. The new FX sensor technology utilizes a patented electro-optical configuration that maintains the same levels of resolution and accuracy found in traditional SPOS sensors. The AccuSizer 780/LVS Large Volume Sizer
The AccuSizer 780/LVS Large Volume Sizer is specifically designed to analyze large volumes of liquid with particles as large as 2000 microns. Often it is imperative to pass large amounts of diluted dispersion through an SPOS sensor. The key to the AccuSizer LVS system is its large volume dilution chamber that combines the ease of use of autodilution with the speed of a quick flushing fluidics system. AccuSizer 780/SIS Syringe Injection Sampler
When volumetric sampling is paramount, the SIS sampler fits the bill. With syringes ranging from 0.5 to 25 ml and a precision stepper motor with over 25000 steps per pull the SIS sampler is a perfect addition to the family of modular instruments. It is specifically suited to applications in the pharmaceutical industry such as USP <788> small and large volume injectables. Now available for use with the AccuSizer 780/SIS is 21 CFR Part 11 compliant software, Calibration and Validation SOPs. AccuSizer 780/OL Online Our patented Autodilution technology has allowed us to take our laboratory instrumentation known for high precision, accuracy, resolution and reproducibility,ａnd carry it to the process line. Simple customizable computer controlled fluid-sampling devices are used to grab a precise aliquot of concentrated in-line dispersion and automatically inject it into the Autodilution system. Then, just as in our laboratory systems, the sample is diluted to the optimal concentration for an SPOS measurement, without regard to its initial concentration or particle size distribution (PSD). The resulting PSDs, with unique single particle resolution are identical to those that historically could only be obtained in the research laboratory. No longer must correlation algorithms and complex statistical tools be developed to compare laboratory findings with online results. The Autodilution module is an integral part of both of our laboratory instruments- the AccuSizer 780 Single Particle Optical Sizer and the Nicomp 380 Submicron Particle Sizer. These laboratory instruments have been modified to meet the rigors imposed by online process monitoring. They have been redesigned utilizing ruggedized com-ponents and are housed in different classes of NEMA enclosures, depending on the application. These vary from dust and waterproof enclosures to explosion-proof modules that can handle even the most aggressive environments, including high pressures and sub-zero temperatures. Multi-port systems are available with specialized software to monitor multiple points in an online process. These reduce costs while maximizing coverage to ensure that quality control requirements are met. Users have a choice of using either an embedded mode Windows based controller or a Programmed Logic Controller (PLC) which are often found in process control systems. In either case the resulting data can be displayed on screen or passed to a Laboratory Information Management System (LIMS) as an ASCII file. It provides for limitless posbcapture data analysis that can easily be customized by the user with common programs found on all modern computer systems. The AccuSizer 780/OL system is able to detect minute amounts of oversized particles in the tail of the process dispersion. It has produced results where the difference between a good and bad sample is determined by a few hundredths percent in volume fraction above a particular critical particle diameter, several standard deviations above the main peak of the distribution. It is also able to detect very small percentages of “fines" in the presence of larger particles. These fines often play an important role in determining the viscosity, flowability and other characteristics of both the process dispersion and the final product. |
工作原理
目錄結構：
1.單顆粒光學傳感技術簡介
2.傳統光阻法和光散法測量粒度的原理
3.PSS的SPOS技術介紹
1、單顆粒光學傳感技術簡介
單顆粒光學傳感技術（Single Particle Optical Sizing, SPOS）是一種用于測量溶劑中懸浮粒子的大小和數量濃度的激光粒度檢測通用技術。在SPOS技術中液體懸浮液中的粒子流經傳感器的樣品池時，在激光光源的照射下，被阻擋或者被散射的光會轉變成脈沖電壓信號，脈沖信號的大小是由粒子的截面面積和物理判定規則即光散射或者光阻共同決定的。光阻也被稱為不透光度或者光消減。而粒子間的相互阻擋和散射是和粒子的大小和濃度是有關系的，利用脈沖幅度分析器和校準曲線便可以得到懸浮粒子的數量濃度和粒度大小分布。傳統光阻法可以測得1.5μm以上的粒子和并具有較高的分辨率。
單顆粒傳感技術（SPOS）常見粒度儀檢測技術在檢測粒徑分布中的重要不足—粒子數量的統計。自AccuSizer 780系列儀器誕生，以往以犧牲精確性和分辨率來換取檢測速度和易用的歷史一去不復返！
粒粒皆清楚，不丟失任何細節。
2.傳統光阻法與光散射法原理
Figure 1 光阻法檢測示意圖
圖1為光阻法檢測原理圖，待測液體流過橫截面很小的流通池，流通池兩側裝有光學玻璃，激光器的光束通過透鏡組準直，光束穿過流通池并被光電探測器所接收。若待測液體中沒有顆粒，則光電探測器接收到的光信號穩定不變，輸出的電壓信號也恒定，將此恒定信號作為基準電壓；若液體中有顆粒物質，顆粒通過流通池傳感區域，將會遮擋激光，光電探測器接收到的光信號減小，產生一個負的脈沖電信號，如下圖2所示。
Figure 2 光電二極管信號
脈沖信號幅度與基準電壓信號有如下關系：
（1）
式（1）中：E為顆粒遮擋引起的脈沖幅度；a為顆粒的有效遮擋面積（等效為球形）;A為光電探測器的有效面積；E0是沒有顆粒時的光電探測器所產生的基準電壓。因此，脈沖信號幅度對應顆粒的大小，脈沖信號個數對應顆粒的數量。
Figure 3 光散射法檢測原理圖
圖3為光散射法檢測原理圖，待測液體流過流通池，流通池兩側裝有光學玻璃，激光器的光束通過透鏡組準直，光束穿過流通池，照射在光陷進上。若待測液體中沒有顆粒，則光電探測器就收不到光信號，若液體中有顆粒，顆粒通過流通池，與激光光束發生散射現象。某一個（或幾個）角度下的散射光通過透鏡收集匯聚到光電探測器上，產生正的電信號脈沖，脈沖信號的幅度和散射光強成正比。根據信號的幅度和個數可以對液體中的微小顆粒進行計數檢測。
當光束照射含有懸浮微粒的液體時光能減弱。根據文獻, 此時懸浮液中微粒會對光產生散射和吸收等作用,因為這些作用導致的光強減弱與微粒的濃度存在線性關系。在文獻中引用了如下公式,來描述當微粒濃度較小時,透射光強與入射光強之間的關系:
它對應于因為散射和吸收而導致光的衰減總量。有米氏散射的理論，隨著微粒的增大，光強大量集中于前向0度角附近，圖1中我們也可以注意到這一點。（4）式中沒有考慮到這樣的事實：在光阻法檢測中，前向0角度附近的散射光仍然能夠被探測器接收，因此必須考慮對散射系數進行修正。實際中（4）式變為：
3.PSS技術的單顆粒光學傳感技術簡介
經過光感區域的粒子由于大小不同，光強隨之產生相應的變化。將探測器收集的光信號轉換成電壓信號，不同的電壓信號對應不同的粒徑大小，從而得到微粒的粒徑。美國PSS粒度儀公司（Particle Sizing Systems）的單顆粒光學傳感技術（Single Particle Optical Sizing，SPOS）是在傳統光阻法（LE）大顆粒光學傳感技術的基礎上加入了激光散射模塊（LS）。在兩個模塊（LE+LS）同時運行的情況下，檢測下限由原來純光阻的1.5μm下探至0.5μm。使得其在大顆粒檢測領域的應用更加的廣泛。
SPOS技術對粒子的信號響應方式是信號與特定粒子相對應的。AccuSizer 780系列儀器中的傳感器通過兩種不同性質的物理作用（）：光消減（light extinction, LE）與光散射（light scattering, LS）對通過傳感器的粒子進行測定。光消減技術檢測通過流動池的光強變化，擁有檢測粒子的粒徑范圍廣且與粒子組份無關等優點。然而，它的靈敏度有限。另一方面，光散射技術具有相對窄的動態粒徑范圍 (取決于檢測器/放大器的飽和值)，但能檢測到小粒徑的粒子，使用大功率激光光源還能檢測到粒徑更小的粒子。通過合并光消減和光散射響應信號，傳感器可同時擁有這兩種方法的優點，因而在不損失單粒子分辨率巨大優勢的前提下擁有相對較廣的動態粒徑范圍。
圖4 PSS的SPOS原理圖
分析方法及原理 | 光阻法（基于單顆粒光學傳感技術） |
測量范圍（傳感器可選） | 0.5-400μm 1.5-400μm 2.0-1000μm 25.0-2500μm 50.0-5000μm |
| 樣品類型 | 水相/有機相 |
通道數量 | 512 |
| 自定義通道數 | 32 |
流速范圍 | 5-120ml/min |
進樣量 | 50μl-1000ml |
進樣方式 | 自動 |
樣品濃度 | 1011個/ml |
符合標準 | USP787、788、789、1788;CP0903 |
流速準確性 | ±5% |
體積準確性 | ±5% |
粒徑準確性 | ±2% |
| 計數準確性 | ±10% |
磁力攪拌模塊 | 標準配置 |
機械攪拌模塊 | 可選配 |
自動進樣器 | 可選配 |
Windows系統 | Windows 7以上專業版操作軟件 |
分析操作軟件 | 標配：符合21CFR PART11規范的法規分析軟件 |
電源選項 | 220 – 240 VAC，50Hz 或100 – 120 VAC，60Hz |
外形尺寸 | 主機：46cm*31cm* 17cm |
重量 | 約21kg |
傳感器 | LE400-05（0.5μm-400μm） LE400-1（1μm-400μm） LE1000-2（2μm-1000μm） LE2500-5（5μm-2500μm） LE5000-50（50μm-5000μm） | 提供了寬泛的測量范圍，客戶可以根據自己實際需要，選擇適合自己樣品的測量范圍的傳感器。 |
Syringe | 選配：1ml， 標配：2.5ml，10ml，25ml | 根據樣品量的不同，選用不同容量的注射器，可以滿足不同的測樣量要求 |
PFA管 | 標配：1/8 選配：1/16 | 根據樣品量的不同，選用不同管徑的高凈PFA管，可以滿足從毫升到微升的測樣需求 |
攪拌臺 | 標配 | 配備可調速式攪拌臺，無需人工攪拌 |
升降臺 | 標配 | 配備自動升降臺，可以根據樣品位置，調整到適宜的取樣高度 |
自動進樣器 | 選配 | 可配備自動進樣器實現多達76個連續樣本分析而無需操作人員的干預。自動化控制，省時省力 |
蠕動泵 | 選配 | 根據樣品量的不同，可以配備蠕動泵進樣方式，滿足超大容量樣品測試需求 |
注射泵 | 10-120ml/min | 配備步進電機驅動的超高精度注射泵，實現對樣品采集的精確控制以及超長的使用壽命； |
Cable | 10/14針 | Counter與Sensor、Sampler的連接采用航空級鋁制插頭，實現超長使用壽命及超高的通訊穩定性； |
清洗套件 | Mirco 90 | 傳感器Flow cell專用清洗套裝，保證在長期使用之后可以恢復清潔狀態； |
性能確認用標粒 | PQ：MML 0.8&2&5 藥典：海岸鴻蒙、USP標準粒子 | 采用符合NIST的進口標準粒子對設備進行性能確認； |
校準用標粒 | Duke：0.5；0.7；0.8；1.0；1.7；2.0；5.0；10；15；25；50；100μm | 采用符合NIST的進口標準粒子對傳感器進行校準； |
軟件 | 標配：Accusizer | 法規軟件滿足21CFR的各項要求；可以滿足各類醫藥客戶對儀器的各類法規要求； |
注射液 | 含有大量不溶性微粒的輸液進入人體可直接造成體溫升高，心跳加快，更甚可導致休克。這是由不溶性微粒在身體某部位疊加堆積造成。主要癥狀有：血管阻塞，刺激發炎，肉芽腫，血液凝結等?，F今各國藥典均把注射劑中的不溶性微粒檢查作為必檢項目之一，隨著檢查要求越發嚴格，FDA最近期望企業能檢測的下限下探至2μm |
尊敬的用戶您好，在對儀器還不了解的情況下，為了讓您可以選擇一款適合貴單位的設備，可以先寄送樣品到我們公司，由我們的技術人員幫您測試樣品，并將測試結果和數據報告發送到您郵箱或者將紙質版寄送到貴單位。
下方鏈接是測試申請表，請下載填寫完整后隨樣品一起寄送過來。
下載鏈接在這里郵寄地址：中國上海閔行區漕河涇浦江高科技園 F區 新駿環路588號23幢402室
郵編：201204
：吳先生（請備注樣品）
電話：
| Nicomp 380 系列彩頁 | ||
| 序號 | 文件類型 | 下載鏈接 |
| 1 |  | PSS_380合集_Brochures_CN_v3.0 |
| 2 | | PSS_N3000_納米粒度儀_flyer_CN_v4.0 |
| 3 | | PSS_Z3000_納米粒度及Zeta電位分析儀_flyer_CN_v4.0 |
| 4 | | PSS_Nicomp_3000_粒度分析儀系列_Brochures_V4.4 |
| AccuSizer 780 系列彩頁 | ||
| 序號 | 文件類型 | 下載鏈接 |
| 1 | | PSS_780合集_Brochures_CN_v3.0 |
| 2 | | PSS_不溶性微粒專題_flyer_CN_v3.0 |
| 3 | | PSS_粒度儀在醫藥行業的應用_flyer_CN_v3.0 |
| 4 | | PSS_A2000_SIS_不溶性微粒檢測儀_flyer_CN_v4.0 |
| 5 | | PSS_A7000_APS_大乳粒檢測儀_flyer_CN_v4.0 |
| 6 | | PSS_A7000_AD_多功能自動計數粒度儀_flyer_CN_v4.0 |
| 7 | | PSS_FMS_flyer_CN_v3.0 |
8 | | PSS_AccuSizer_2000_不溶性微粒分析儀系列_Brochures_V4.4 |
| 9 | | PSS_AccuSizer_7000_計數粒度分析儀系列_Brochures_V4.4 |
| 10 | | PSS_AccuSizer_9000_高濃度納米顆粒計數器系列_Brochures_V4.4 |
| 11 | | PSS_FMS_在線粒度儀系列_Brochures_V4.4 |
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